BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANTAGE ANKLE COMPONENTS

    MDR report key: 20613115 · Received November 5, 2024

    Report

    Report Number
    1038671-2024-04245
    Event Type
    Injury
    Date Received
    November 5, 2024
    Date of Event
    June 27, 2024
    Report Date
    November 11, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    HSN
    PMA / PMN Number
    K152217
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (D10) REPORTED CONCOMITANT DEVICE(S): 350-12-03 - TIBIAL PLATE FB SZ 3 RT: 7303546. 350-24-42 - VIT E LINER-R-SZ 2-10MM: A899270. 350-02-02 - TALAR IMPLANT SZ 2 RT: A151017. 350-10-03 - ANKLE SZ 3 LOCKING CLIP: 6777108.

    Description of Event or Problem · 0

    APPROXIMATELY 1 MONTH(S) AND 26 DAY(S) POST-OPERATIVE OF A RIGHT TAA, IT WAS REPORTED VIA CLINICAL STUDY THAT THE PATIENT EXPERIENCED DVT (DEEP VEIN THROMBOSIS). THE PATIENT DEVELOPED DVT IN OPERATIVE LEG. IT WAS ALSO NOTED THAT THIS IS A LIFE THREATENING EVENT AND THAT THERE IS A REASONABLE TEMPORAL RELATIONSHIP TO THE PROCEDURE, WHICH FOLLOWS A KNOWN PATTERN OF RESPONSE TO INTERVENTION. THE PATIENT WAS GIVEN MEDICATION, AND THE EVENT IS NOW CONSIDERED CONTINUING. THE CLINICAL REPORT INDICATES THAT THIS EVENT IS DEFINITELY NOT RELATED TO THE DEVICE(S) AND POSSIBLY RELATED TO THE PROCEDURE. THIS WAS REPORTED THROUGH CLINICAL TRIAL STUDY DATA COLLECTION ACTIVITIES AND NO OTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1461695 VANTAGE ANKLE COMPONENTS PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER HSN EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male Other SEE H11